TriangleNCT01673867 · OUTCOME
Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Randomization until 413 deaths, up to March 2015 (approximately 29 months)
What was measured
Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.
Analysis population: All randomized participants
Groups in this outcome
Nivolumab
Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Docetaxel
Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
| Group | Source count |
|---|---|
| Nivolumab | 292 |
| Docetaxel | 290 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 12.19 | Not reported | 9.66 | 14.98 | Not reported |
| Docetaxel | 9.36 | Not reported | 8.05 | 10.68 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.92
- ci Upper Limit
- 0.89
- estimate Comment
- HR = Nivolumab over docetaxel
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0015
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.92
- ci Upper Limit
- 0.89
- estimate Comment
- HR = Nivolumab over docetaxel
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0015
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.66
- upper Limit
- 14.98
- value
- 12.19
- group Id
- OG001
- lower Limit
- 8.05
- upper Limit
- 10.68
- value
- 9.36
- denoms
- counts
- group Id
- OG000
- value
- 292
- group Id
- OG001
- value
- 290
- units
- Participants
- description
- Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
- id
- OG000
- title
- Nivolumab
- description
- Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
- id
- OG001
- title
- Docetaxel
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- Randomization until 413 deaths, up to March 2015 (approximately 29 months)
- title
- Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice